Job Description

About the Company: A small but well-established international biopharma startup based in St. Louis, Missouri, and focused on a novel immunotherapy treatment for cancer patients with solid, metastatic tumors – seeks a qualified medical professional to serve as Medical Monitor for the Company’s multi-national clinical trials. Candidate would have the option of working remotely or from the company’s headquarters office. The Company is also open to negotiating alternative work-schedule arrangements (e.g. working fewer than five days a week) if desired and appropriate based on workload. The ideal candidate will be an excellent communicator with the ability to integrate seamlessly into a small, tightknit team.

Duties:

• Develop strategies and plan and direct the development of clinical programs to integrate Immunophotonics, Inc. compounds into the standard practice of oncology.
• Use medical expertise to edit and review clinical protocols, developing statistical plans, regulatory submissions and other documents to support the execution of the clinical strategy.
• Ensure compliance with ethical guidelines, Good Clinical Practice (GCP), and regulatory requirements.
• Orchestrate and manage medical aspects of regulatory strategies and interactions with health authorities.
• Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
• Respond to queries related to the clinical trial.
• Interact with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders.
• Train site staff and investigators on the therapeutic area, protocol requirements, and safety reporting.
• Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy.
• Represent the Company and its programs to external audiences, including the investment, medical, and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners.
• Prepare materials pertaining to clinical/medical topics at the request of management for presentations, events, conferences, or public dissemination.
• Serve as medical monitor for global trials for ongoing studies and safety review.
• Evaluate potential risks and assess ongoing safety of the trial participants, including identifying, reporting, and managing any adverse events or reactions reported by trial participants.
• Make recommendations regarding dose modifications, treatment discontinuation, or other safety measures based on trial data.
• Report on clinical and medical matters to the Immunophotonics Board of Directors.

Qualifications

• Medical degree and valid license to practice.
• Proven experience in clinical research or related field.
• Excellent communication and presentation skills.
• Ability to interpret and apply clinical data and statistical results.
• Familiarity with Good Clinical Practices (GCP).
• Strong understanding of clinical trial methodology and regulations.
• Excellent analytical and decision-making skills.
• Proficiency in using clinical trial management software.

Additional Information

• Job Title: Medical Monitor
• Work Environment: Primarily remote. Some travel may be required for site visits or investigator meetings, and occasional visits to the Company’s headquarters in St. Louis, Missouri, may be required.
• Reporting Structure: Reports to the VP of Clinical and Regulatory Affairs.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Location: Remote
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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